Would you like to be part of a team that takes a product from design and all the way through to final manufacture? We are looking for an experienced Quality Engineer who will be responsible for the improvement of quality systems processes to ensure regulatory compliance to relevant company standards and Good Manufacturing Practice.
As a business they offer a competitive package with a high-rate pension and flexible working hours.
If the above sounds like a good match or if you want any further details please get in contact, the role is quite varied, and the spec is flexible for the right person and attitude.
Responsibilities:
- Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR).
- Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority and quality standards
- Provide effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations
- Provide reports to management to enable them to monitor system performance.
- Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation.
- Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.
- Support and perform training throughout the company to maintain awareness of the Quality System requirements.
- Support and conduct internal and inter-company Quality System Audits in line with local and group objectives.
Experience/Qualifications:
- Ideally degree/HND/HNC educated in a engineering discipline
- 2+ years’ experience working in a Quality Assurance environment within a highly regulated industry
- Knowledge of Quality Management Systems and ISOs.